Current through Supplement No. 395, January, 2025
1.
Notification and withdrawal from sections
33.1-24-05-310 through
33.1-24-05-320 for
health care facilities managing hazardous waste pharmaceuticals.
a.
Notification. A health care
facility must notify the department using the site identification form
(environmental protection agency form 8700-12), that it is a health care
facility operating under sections
33.1-24-05-310 through
33.1-24-05-320. A health
care facility is not required to fill out box 10.B. (waste codes for federally
regulated hazardous waste) of the site identification form with respect to its
hazardous waste pharmaceuticals. A health care facility must submit a separate
notification (site identification form) for each site or environmental
protection agency identification number.
(1)
A health care facility that already has an environmental protection agency
identification number shall notify the department using the site identification
form (environmental protection agency form 8700-12) that it is a health care
facility as part of its next biennial report, if it is required to submit one;
or if not required to submit a biennial report, within sixty days of July 1,
2021, or within sixty days of becoming subject to this subpart.
(2) A health care facility that does not have
an environmental protection agency identification number shall obtain one by
notifying the department, using the site identification form (environmental
protection agency form 8700-12), that it is a health care facility as part of
its next biennial report, if it is required to submit one; or if not required
to submit a biennial report, within sixty days of July 1, 2021, or within sixty
days of becoming subject to this subpart.
(3) A health care facility must keep a copy
of its notification on file for as long as the health care facility is subject
to sections
33.1-24-05-310 through
33.1-24-05-320.
b.
Withdrawal. A health care
facility that operated under sections
33.1-24-05-310 through
33.1-24-05-320, but is
no longer subject to these requirements, because it is a very small quantity
generator operating under section
33.1-24-03-26
and elects to withdraw from this subpart, shall notify the department using the
site identification form (environmental protection agency form 8700-12) that it
is no longer operating under these sections. A health care facility is not
required to fill out box 10.B. (waste codes for federally regulated hazardous
waste) of the site identification form with respect to its hazardous waste
pharmaceuticals. A health care facility shall submit a separate notification
(site identification form) for each environmental protection agency
identification number.
(1) A health care
facility must submit the site identification form notifying that it is
withdrawing from these requirements before it begins operating under the
conditions for exemption in section
33.1-24-03-26.
(2) A health care facility shall keep a copy
of its withdrawal on file for three years from the date of signature on the
notification of its withdrawal.
2.
Training of personnel managing
noncreditable hazardous waste pharmaceuticals at health care facilities.
A health care facility shall ensure all personnel that manage noncreditable
hazardous waste pharmaceuticals are thoroughly familiar with proper waste
handling and emergency procedures relevant to their responsibilities during
normal facility operations and emergencies.
3.
Hazardous waste determination for
noncreditable pharmaceuticals. A health care facility that generates a
solid waste that is a noncreditable pharmaceutical shall determine whether that
pharmaceutical is a hazardous waste pharmaceutical (i.e., it exhibits a
characteristic identified in sections
33.1-24-02-10
through
33.1-24-02-14
or is listed in sections
33.1-24-02-15
through
33.1-24-02-19)
to determine whether the waste is subject to the requirements in sections
33.1-24-05-310 through
33.1-24-05-320. A health
care facility may choose to manage its nonhazardous waste pharmaceuticals as
noncreditable hazardous waste pharmaceuticals under these
requirements.
4.
Standards
for containers used to accumulate noncreditable hazardous waste pharmaceuticals
at health care facilities.
a. A health
care facility shall place noncreditable hazardous waste pharmaceuticals in a
container that is structurally sound, compatible with its contents, and that
lacks evidence of leakage, spillage, or damage that could cause leakage under
reasonably foreseeable conditions.
b. A health care facility that manages
ignitable or reactive noncreditable hazardous waste pharmaceuticals, or that
mixes or commingles incompatible noncreditable hazardous waste pharmaceuticals
shall manage the container so that it does not have the potential to:
(1) Generate extreme heat or pressure, fire
or explosion, or violent reaction;
(2) Produce uncontrolled toxic mists, fumes,
dusts, or gases in sufficient quantities to threaten human health;
(3) Produce uncontrolled flammable fumes or
gases in sufficient quantities to pose a risk of fire or explosions;
(4) Damage the structural integrity of the
container of noncreditable hazardous waste pharmaceuticals; or
(5) Through other like means threaten human
health or the environment.
c. A health care facility shall keep
containers of noncreditable hazardous waste pharmaceuticals closed and secured
in a manner that prevents unauthorized access to its contents.
d. A health care facility may accumulate
noncreditable hazardous waste pharmaceuticals and nonhazardous noncreditable
waste pharmaceuticals in the same container, except that noncreditable
hazardous waste pharmaceuticals prohibited from being combusted because of the
dilution prohibition of section
33.1-24-05-252
must be accumulated in separate containers and labeled with all applicable
hazardous waste numbers, i.e., hazardous waste codes.
5.
Labeling containers used to
accumulate noncreditable hazardous waste pharmaceuticals at health care
facilities. A health care facility shall label or clearly mark each
container of noncreditable hazardous waste pharmaceuticals with the phrase
"Hazardous Waste Pharmaceuticals".
6.
Maximum accumulation time for
noncreditable hazardous waste pharmaceuticals at health care facilities.
a. A health care facility may accumulate
noncreditable hazardous waste pharmaceuticals on site for one year or less
without a permit.
b. A health care
facility that accumulates noncreditable hazardous waste pharmaceuticals onsite
shall demonstrate the length of time that the noncreditable hazardous waste
pharmaceuticals have been accumulating, starting from the date it first becomes
a waste. A health care facility may make this demonstration by any of the
following methods:
(1) Making or labeling the
container of noncreditable hazardous waste pharmaceuticals with the date that
the noncreditable hazardous waste pharmaceuticals became a waste;
(2) Maintaining an inventory system that
identifies the date the noncreditable hazardous waste pharmaceuticals being
accumulated first became a waste; or
(3) Placing the noncreditable hazardous waste
pharmaceuticals in a specific area and identifying the earliest date any of the
noncreditable hazardous waste pharmaceuticals in the area became a
waste.
7.
Land disposal restrictions for noncreditable hazardous waste
pharmaceuticals. The noncreditable hazardous waste pharmaceuticals
generated by a health care facility are subject to the land disposal
restrictions of sections
33.1-24-05-250
through
33.1-24-05-309. A health
care facility that generates noncreditable hazardous waste pharmaceuticals
shall comply with the land disposal restrictions in accordance with subsection
1 of section
33.1-24-05-256
requirements, except that it is not required to identify the hazardous waste
numbers (i.e., hazardous waste codes) on the land disposal restrictions
notification.
8.
Procedures
for health care facilities for managing rejected shipments of noncreditable
hazardous waste pharmaceuticals. A health care facility that sends a
shipment of noncreditable hazardous waste pharmaceuticals to a designated
facility with the understanding that the designated facility can accept and
manage the waste, and later receives that shipment back as a rejected load in
accordance with the manifest discrepancy provisions of section
33.1-24-05-39
may accumulate the returned noncreditable hazardous waste pharmaceuticals
onsite for up to an additional ninety days provided the rejected or returned
shipment is managed in accordance with subsections 4 and 5. Upon receipt of the
returned shipment, the health care facility shall:
a. Sign either:
(1) Item 18c of the original manifest, if the
original manifest was used for the return shipment; or
(2) Item 20 of the new manifest, if a new
manifest was used for the returned shipment.
b. Provide the transporter a copy of the
manifest;
c. Within thirty days of
receipt of the rejected shipment, send a copy of the manifest to the designated
facility that returned the shipment to the health care facility; and
d. Within ninety days of receipt of the
rejected shipment, transport or offer for transport the returned shipment in
accordance with the shipping standards of subsection 1 of section
33.1-24-05-318.
9. Reporting by health care facilities for
noncreditable hazardous waste pharmaceuticals.
a. Biennial reporting by health care
facilities. Health care facilities are not subject to biennial reporting
requirements under section
33.1-24-03-14,
with respect to noncreditable hazardous waste pharmaceuticals managed under
sections
33.1-24-05-310 through
33.1-24-05-320.
b. Exception reporting by health care
facilities for a missing copy of the manifest.
(1) For shipments from a health care facility
to a designated facility, if a health care facility does not receive a copy of
the manifest with the signature of the owner or operator of the designated
facility within sixty days of the date of the noncreditable hazardous waste
pharmaceuticals were accepted by the initial transporter, the health care
facility shall submit:
(a) A legible copy of
the original manifest, indicating the health care facility has not received
confirmation of delivery, to the department; and
(b) A handwritten or typed note on the
manifest itself, or on an attached sheet of paper, stating the return copy was
not received and explaining the efforts taken to locate the noncreditable
hazardous waste pharmaceuticals and the results of those efforts.
(2) For shipments rejected by the
designated facility and shipped to an alternate facility, if a health care
facility does not receive a copy of the manifest for a rejected shipment of the
noncreditable hazardous waste pharmaceuticals that is forwarded by the
designated facility to an alternate facility using appropriate manifest
procedures, with the signature of the owner or operator of the alternate
facility, within sixty days of the date the noncreditable hazardous waste was
accepted by the initial transporter forwarding the shipment of noncreditable
hazardous waste pharmaceuticals from the designated facility to the alternate
facility, the health care facility shall submit:
(a) A legible copy of the original manifest,
indicating the health care facility has not received confirmation of delivery,
to the department; and
(b) A
handwritten or typed note on the manifest itself, or on an attached sheet of
paper, stating the return copy was not received and explaining the efforts
taken to locate the noncreditable hazardous waste pharmaceuticals and the
results of those efforts.
c. Additional reports. The department may
require health care facilities to furnish additional reports concerning the
quantities and disposition of noncreditable hazardous waste
pharmaceuticals.
10.
Recordkeeping by health care facilities for noncreditable hazardous waste
pharmaceuticals.
a. A health care
facility shall keep a copy of each manifest signed in accordance with
subsection 1 of section
33.1-24-03-07
for three years or until it receives a signed copy from the designated facility
which received the noncreditable hazardous waste pharmaceuticals. This signed
copy must be retained as a record for at least three years from the date the
waste was accepted by the initial transporter.
b. A health care facility shall keep a copy
of each exception report for a period of at least three years from the date of
the report.
c. A health care
facility shall keep records of any test results, waste analyses, or other
determinations made to support its hazardous waste determination consistent
with subsection 6 of section
33.1-24-03-02
for at least three years from the date the waste was last sent to an onsite or
offsite treatment, storage, or disposal. A health care facility that manages
all of its noncreditable nonhazardous waste pharmaceuticals as noncreditable
hazardous waste pharmaceuticals is not required to keep documentation of
hazardous waste determinations.
d.
The periods of retention referred to in this section are extended automatically
during the course of any unresolved enforcement action regarding the regulated
activity, or as requested by the department.
e. All records must be readily available upon
request by an inspector.
11.
Response to spills of noncreditable
hazardous waste pharmaceuticals at health care facilities. A health care
facility immediately shall contain all spills of noncreditable hazardous waste
pharmaceuticals and manage the spill cleanup materials as noncreditable
hazardous waste pharmaceuticals in accordance with the requirements in sections
33.1-24-05-310 through
33.1-24-05-320.
12.
Accepting noncreditable hazardous
waste pharmaceuticals from an offsite health care facility that is a very small
quantity generator. A health care facility may accept noncreditable
hazardous waste pharmaceuticals from an offsite health care facility that is a
very small quantity generator under section
33.1-24-03-26
without a permit or without having interim status, provided the receiving
health care facility:
a. Is under the control
of the same person, as defined in section
33.1-24-03-26,
as the very small quantity generator health care facility that is sending the
noncreditable hazardous waste pharmaceuticals offsite ("control", for the
purposes of this section means the power to direct the policies of the health
care facility, whether by the ownership of stock, voting rights, or otherwise,
except that contractors who operate health care facilities on behalf of a
different person as defined in section
33.1-24-03-26
may not be deemed to "control" such health care facilities) or has a
contractual or other documented business relationship whereby the receiving
health care facility supplies pharmaceuticals to the very small quantity
generator health care facility;
b.
Is operating under this section for the management of its noncreditable
hazardous waste pharmaceuticals;
c.
Manages the noncreditable hazardous waste pharmaceuticals that it receives from
offsite in compliance with sections
33.1-24-05-310 through
33.1-24-05-320;
and
d. Keeps records of the
noncreditable hazardous waste pharmaceuticals shipments it receives from
offsite for three years from the date that the shipment is
received.
General Authority: NDCC 23.1-04-03
Law Implemented: NDCC 23.1-04-03,
23.1-04-05; S.L. 2017, ch. 199, §
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